Responsible person for pharmacovigilance system
The holder of the marketing authorisation must have a permanently available person responsible for the pharmacovigilance system who is responsible for the establishment and maintenance of the pharmacovigilance system. The person responsible for pharmacovigilance system: is responsible for the establishment and maintenance of the pharmacovigilance system to ensure the collection and comparison of data on all suspected adverse reactions of the medicinal product; has ensured access to the main dossier on the pharmacovigilance system and sufficient jurisdiction for ensuring that the content of the main dossier on the pharmacovigilance system is accurate and regularly updated to reflect the needs of the pharmacovigilance system; has sufficient jurisdiction to impact the implementation of the quality system and pharmacovigilance activities; has an overview of the safety profiles of medicinal products and safety issues and considers as well as monitors the conditions of launching medicinal products and other obligations that affect the safety of medicinal products and the measures for reducing risks; has sufficient jurisdiction with regard to the content of risk management plans, cooperates at the review and approval of protocols of clinical trials after acquiring the marketing authorisation; ensures appropriate quality, accuracy and completion of data on the pharmacovigilance of the medicinal product that are submitted to the competent authority and to all requirements of the competent authority to submit additional data required for assessing benefits and risks connected with the medicinal product, replies in entirety and immediately and submits data on sales; submits all other information relevant for the assessment of benefits and risks connected to the medicinal product to the competent authority, including appropriate data from clinical trials after obtaining the marketing authorisation; guarantees 24-hour availability; has appropriate education, knowledge and skills.
Conditions and evidence
Last updated: 21. 12. 2015